AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE by AXIAMED, INC.

The intended use of the AXIAMED Trans-Sacral Spinal Access Device is for minimally invasive access to the anterior portion of the lower spine for the purpose of assisting in the treatment of decompression of the lumbar disc or the performance of lumbar discectomy.

Device Description

The AXIAMED Trans-Sacral Spinal Access Device is for minimally invasive access to the anterior lower spine and consists of the following components:

Blunt Trocar with Trocar Guide Stylet Threaded Guide Dilator Sheath, Small Dilator Sheath, Large Threaded Guide Sheath, 3mm Threaded Guide Sheath, 4mm Drill Bit, 3 mm Drill Bit, 4mm Delivery Cannula with blunt stylet

AI/ML Overview

The provided document is a 510(k) summary for the AXIAMED Trans-Sacral Spinal Access Device, which is a regulatory submission to the FDA. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document states that the FDA reviewed the premarket notification and determined the device is "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This determination is based on a comparison to existing devices, not on specific performance criteria met through a dedicated study with ground truth, expert review, or statistical analysis (such as sample size, effect size, or MRMC studies).

Therefore, I cannot provide the requested information from the given text. The 510(k) summary focuses on device description, predicate devices, and the FDA's regulatory determination of substantial equivalence. It does not include the detailed study design and acceptance criteria typically found in clinical trial reports or validation studies.

Summary

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510(k) Summary of Safety and Effectiveness

In Accordance with CFR 807.92 (April 26, 1992), the following information is submitted:

1.	Name:	AXIAMED, Inc.
	Address:	5200 Willson RoadSuite 150Edina, MN 55424

952 836-2660 Phone: 952 836-2661 Fax:

W. Allen Putnam Contact: Date of Summary Preparation: July 12, 2002

Name of Device: AXIAMED Trans-Sacral Spinal Access Device 2. Generic Name: Rigid Endoscope and Instrument Set
1. Predicate Devices:

Surgical Dynamics, Inc., 30K Working Channel Scope and instrument kit for Discectomy

Argus Medical Company Laparoscopic Discectomy Instrument System

The Nucleotome System and Probe Kits.

Surgical dynamics Discography System

Sofamor Danek USA, Inc., Micro Endo Instruments

Device Description: 4.
The AXIAMED Trans-Sacral Spinal Access Device is for minimally invasive access to the anterior lower spine and consists of the following components:

Kc20457

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The eagle faces right and is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

Public Health Service

Food and Drug Administration . 9200 Corporate Boulevard Rockville MD 20850.

SEP 2, 6 2002

Mr. W. Allen Putnam AXIAMED, Inc. 5200 Wilson Road, Suite 150 Edina, Minnesota 55424

Re: K020457

Trade Name: AXIAMED Trans-Sacral Spinal Access Device Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: July 12, 2002 Received: July 15, 2002

Dear Mr. Putnam:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. W. Allen Putnam

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Atypt Rhodes
Celia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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020457

INDICATION FOR USE

Hyde Rhode

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.